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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed.

Uhl has served as head of OGD for two years, first as acting director starting in March 2013, and then as the office's permanent director in January 2015.

Under her leadership, OGD has been implementing huge changes spurred by the passage of the Food and Drug Administration Safety and Innovation Act's (FDASIA) Generic Drug User Fee Act (GDUFA). The law created new funding arrangements meant to allow OGD to hire hundreds more regulatory staff members, but also required the agency to make sustained improvements in its regulatory review times and processes.

But as first reported by former acting deputy director of OGD, Bob Pollock, Uhl is taking medical leave at the end of March.

Uhl is being treated for colorectal cancer and will be on leave for "several months" effective 30 March 2015, FDA told Regulatory Focus in an emailed statement.

In her absence, OGD will be lead on an acting basis by John peters, now the acting director of the Office of Bioequivalence. As reported by Regulatory Focus in February, OGD does not currently have a deputy director to succeed Uhl in her absence.

Dale Conner will become acting director of the Office of Bioequivalence, FDA said.